Insufflation pump

ABSTRACT

An insufflation pump includes a pump body having a first end and a second end. The pump body includes a syringe mechanism at the first end and an actuation mechanism at the second end. The syringe mechanism includes a plunger. The plunger of the syringe mechanism and the actuation mechanism are linked by a toggle assembly facilitating transfer of power from the actuation mechanism to the syringe mechanism.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/047,054, entitled “INSUFFLATION PUMP,” filed Feb. 18, 2016, whichclaims the benefit of U.S. Provisional Application Ser. No. 62/118,127,entitled “INSUFFLATION PUMP,” filed Feb. 19, 2015.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The invention relates to an insufflation pump.

2. Description of the Related Art

Most vascular procedures are now performed in an endovascular fashion;that is, by way of a catheter placed inside of an artery or vein. Thebenefit of an endovascular, versus a traditional “open”, surgicalprocedure is the greatly decreased morbidity and mortality afforded bythe endovascular route, while affording similar overall outcomes.Instead of the traditional surgical bypass procedure performed on theheart, legs, as well as other body parts, endovascular percutaneoustransluminal angioplasty, or PTA, is now the standard of care fortreating narrowed or blocked arteries and veins. Angioplasty isperformed to dilate arteries, veins and other closed, tubular structureswithin the body. These additional structures may include the biliarytree, ureters, kidneys, as well as other tissue which needs to beexpanded radially. Its worldwide acceptance has resulted in millions ofPTA, or “angioplasty” procedures performed in the United States andabroad yearly.

When performing angioplasty, the physician advances a specializedcatheter, which contains a pre-mounted balloon at its tip, over a guidewire and into the area of abnormal narrowing in the artery or vein. Thiscatheter advancement is accomplished utilizing fluoroscopic guidance,which is essentially a “real time” continuous x-ray image. Once theballoon or angioplasty catheter is precisely placed into the desiredarea within the blood vessel, the catheter-mounted balloon can beinflated, thusly performing angioplasty within the artery or vein. Theinflation of the balloon is accomplished by the use of a device known asan insufflator.

All currently-available insufflators require two hands to inflate theballoon: one to hold the device and one to incrementally increase thefluid forced into the balloon from the insufflator by rotating athreaded screw. A pressure gauge is commonly located on the body of theinsufflator so that the balloon can be inflated to a desired atmosphericpressure. The use of an insufflator, as opposed to a simple syringe,results in accurate, reproducible pressures within the angioplastyballoon. Because operation of the insufflator requires two hands, asecond physician, or technician, is needed to hold the angioplastycatheter in the proper position during the angioplasty procedure andinflation of the balloon. The primary physician must, therefore, decidewhich portion of the procedure is most important; that is, controllinginflation rates and pressures in operating the insufflator versuscontrolling the positioning of the balloon catheter. Not properlypositioning the angioplasty balloon may result in damage to a normalportion of the vessel, while not holding the catheter in place couldresult in undesired movement of the angioplasty balloon, with subsequenttraumatic vessel dissection. This results in, as a best-case scenario,inadequate angioplasty due to improper balloon placement, or in theworse scenario, vessel dissection and possible death.

Most recently, with the advent of balloon kyphoplasty for the repair ofvertebral compression fractures of the spine, balloon catheters havealso been used to expand compressed bone. These procedures similarlyrequire the use of an insufflator in the inflation of the ballooncatheter and are consequently beset with the same problems.

Currently, insufflators are filled with a mixture of radiopaque contrastmaterial and sterile saline during a procedure. This mixture allows theangioplasty balloon to be observed under fluoroscopy by the operatingphysician, and its precise location can be directly observed in realtime. In addition, the response of the vessel to angioplasty can bemonitored indirectly by viewing the form of the angioplasty balloonusing fluoroscopy: a narrow balloon suggests a poorly dilated vesselwhile a fully expanded balloon suggests a successfully dilated vessel.

With the foregoing in mind, an insufflator adapted for one-handedoperation has been developed; as such, it is both held and deployedutilizing one hand as opposed to two. By allowing one hand to be freed,the physician can thusly hold the catheter in its proper position, whilecontrolling both the rate of pressure rise and total pressure achievedby inflation of the angioplasty catheter.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide aninsufflation pump including a pump body having a first end and a secondend. The pump body includes a syringe mechanism at the first end and anactuation mechanism at the second end. The syringe mechanism includes aplunger. The plunger of the syringe mechanism and the actuationmechanism are linked by a toggle assembly facilitating transfer of powerfrom the actuation mechanism to the syringe mechanism.

It is also an object of the present invention to provide an insufflationpump wherein the syringe mechanism includes a syringe barrel and theplunger is positioned within the syringe barrel for movement therein,the syringe barrel is integrally formed with the pump body and includesa distal, first end and a proximal, second end.

It is another object of the present invention to provide an insufflationpump wherein the syringe barrel includes a pressure gauge incommunication with an interior of the syringe barrel for measuringapplied pressure.

It is a further object of the present invention to provide aninsufflation pump wherein the distal, first end of the syringe barrelincludes an outlet port through which fluid is dispensed or withdrawn asthe plunger moves between the proximal, second end of the syringe barrelof the syringe barrel and the distal, first end of the syringe barrel.

It is also an object of the present invention to provide an insufflationpump wherein the outlet port is shaped and dimensioned for selectiveattachment of a catheter thereto.

It is another object of the present invention to provide an insufflationpump wherein the plunger includes a plunger shaft having a first end towhich a seal member is mounted and a second end which is acted upon bythe actuation mechanism.

It is a further object of the present invention to provide aninsufflation pump wherein the plunger shaft includes ratchet teeth on anouter surface of the plunger shaft for controlling movement of theplunger shaft in only one direction.

It is also an object of the present invention to provide an insufflationpump wherein the pump body includes an access opening shaped anddimensioned for the passage of the toggle assembly therethrough.

It is another object of the present invention to provide an insufflationpump wherein the actuation mechanism includes a pistol grip having afixed, handheld lever portion and a spring loaded oscillating leverportion, the toggle assembly being coupled between the oscillating leverportion and the plunger of the syringe assembly.

It is a further object of the present invention to provide aninsufflation pump wherein the toggle assembly includes a first linkagemember, a second linkage member, a third linkage member and a fourthlinkage member.

It is also an object of the present invention to provide an insufflationpump including a push button stop utilized to adjust positioning of thetoggle assembly.

It is another object of the present invention to provide an insufflationpump wherein a first end of the first linkage member is fixedly securedto a second end of the oscillating lever portion such that the secondend of the first linkage member moves about an arc defined by rotationof the oscillating lever portion, a first end of the second linkagemember is pivotally connected to a second end of the first linkagemember, a second end of the second linkage member is pivotally connectedto both respective second ends of the third and fourth linkage members,and a first end of the fourth linkage member is pivotally secured to thepump body while a first end of the third linkage member is incommunication with the plunger for driving the plunger forward as theoscillating lever portion is actuated.

It is a further object of the present invention to provide aninsufflation pump wherein the first end of the fourth linkage member ispivotally mounted to the pump body and unable to move along a length ofthe pump body, and the first end of the third linkage member is causedto move a set distance.

It is also an object of the present invention to provide an insufflationpump wherein a second end of a plunger shaft of the plunger has achannel beam cavity into which the first end of the third linkage membersits for actuation of the plunger shaft along a length of the pump body.

It is another object of the present invention to provide an insufflationpump wherein the first end of the third linkage member is secured to acarriage member having a diametrically oriented guide pin that issecured to the first end of the third linkage member and that passesthrough the plunger shaft, such that the carriage member engages theplunger shaft via a locking pin during forward motion of the thirdlinkage member and the locking pin disengages from the plunger shaftduring rearward motion of the third linkage member and the carriagemember.

Other objects and advantages of the present invention will becomeapparent from the following detailed description when viewed inconjunction with the accompanying drawings, which set forth certainembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of the insufflation pump in accordance with thepresent invention.

FIG. 2 is a top view of the insufflation pump in accordance with thepresent invention.

FIG. 3 is a cross sectional view of the insufflation pump.

FIGS. 4-6 are cross sectional views showing the insufflation pump invarious stages of use.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The detailed embodiments of the present invention are disclosed herein.It should be understood, however, that the disclosed embodiment ismerely exemplary of the invention, which may be embodied in variousforms. Therefore, the details disclosed herein are not to be interpretedas limiting, but merely as a basis for teaching one skilled in the arthow to make and/or use the invention.

Referring to FIGS. 1 to 6, an insufflation pump 10 is disclosed. Theinsufflation pump 10 allows for single handed actuation for inflation ofdilatation balloons and other inflatable devices employed during medicalprocedures.

The insufflation pump 10 includes a pump body 12 having a first end 14and a second end 16. The first end 14 is provided with a syringemechanism 18 and the second end 16 is provided with an actuationmechanism 20. The syringe mechanism 18 and the actuation mechanism 20are linked by a toggle assembly 22 facilitating the transfer of powerfrom the actuation mechanism 20 to the syringe mechanism 18.

The insufflation pump 10 includes a plunger 26 of a syringe mechanism 18attached to a lever system, composed of the actuation mechanism 20 andtoggle assembly 22, which greatly amplifies the mechanical advantagenecessary to create the large atmospheric pressures needed for adequatecatheter balloon inflation. Once filled with radiopaque contrast andsaline, the entire angioplasty process may be performed by a singlephysician. One hand holds the angioplasty catheter while the other handis used to activate the insufflation pump 10 of the present invention.In this manner, a more precise, controlled angioplasty may be performedsince one person controls both the placement as well as the inflation ofthe balloon.

First considering the syringe mechanism 18 at the first end 14 of thepump body 12, the syringe mechanism 18 includes a syringe barrel 24 anda plunger 26 positioned within the syringe barrel 24 for movementtherein. The syringe barrel 24 is integrally formed with the pump body12 and includes a proximal, second end 28 and a distal, first end 30.The syringe barrel 24 also includes a pressure gauge 27 in communicationwith the interior of the syringe barrel 24 for measuring appliedpressure. The proximal, second end 28 is closed by the plunger 26 whilethe distal, first end 30 includes an outlet port 32 through which fluidis dispensed or withdrawn as the plunger 26 moves between the proximal,second end 28 of the syringe barrel 24 and the distal, first end 30 ofthe syringe barrel 24. The outlet port 32 is shaped and dimensioned forselective attachment of a catheter to the syringe barrel 24 for thetransfer of fluid to and from the syringe barrel 24, that is, betweenthe dilatation catheter and the syringe mechanism 18. The outlet port 32at the distal, first end 30 of syringe barrel 24 is closed by the sealmember 34 of plunger 26 when the piston is in its fully extendedposition adjacent the distal, first end 30.

The creation of a sealed environment within the syringe barrel 24, inparticular, between the outlet port 32 and the plunger 26, is achievedby the provision of a seal member 34 about the circumference of theplunger 26. In particular, the plunger 26 includes a plunger shaft 44having a first end 46 to which the seal member 34 is mounted and asecond end 48 which is acted upon by the actuation mechanism 20 in themanner discussed below in greater detail. The seal member 34 is shapedand dimensioned to engage the inner wall 25 of the syringe barrel 24. Assuch, fluid is prevented from escaping distally of the plunger 26 as itmoves within the syringe barrel 24. In addition, and when the outletport 32 is connected to a dilatation catheter, a closed system isachieved wherein fluid may move between the syringe barrel 24 and thedilatation catheter but will not escape the confines of the syringebarrel 24 and dilatation catheter. Consequently, when the plunger 26moves toward the outlet port 32, fluid is forced out of the syringebarrel 24 and into the dilatation catheter. When the plunger 26 is moveddistally away from the outlet port 32, a vacuum is formed drawing fluidfrom the dilatation catheter back into the syringe barrel 24.

As will be appreciated after reading the following disclosure regardingthe actuation mechanism 20, the pump body 12 is provided with an accessopening 36 for the toggle assembly 22, that is, the access opening 36 isshaped and dimensioned for the passage of the toggle assembly 22therethrough. The access opening 36 is sealed from fluid communicationwith the fluid being moved between the syringe barrel 24 and thedilatation catheter by the provision of the seal member 34 about thecircumference of the plunger 26. The seal member 34 of the plunger 26creates a barrier separating the access opening 36 from the fluid andallowing the syringe mechanism 18 to maintain a closed system whilepermitting the actuation mechanism 20 to link with the plunger 26 forcausing movement thereof.

With regard to the actuation mechanism 20, it includes a pistol grip 60having a fixed, handheld lever portion 62 and a spring loadedoscillating lever portion 64. Movement of the pivoted, oscillating leverportion 64 from its rest configuration (with the fixed, handheld leverportion 62 and the spring 70 loaded oscillating lever portion 64 spacedfrom each other as shown in FIG. 3) forces the plunger 26 and theplunger shaft 44 to move to the right down the syringe barrel 24 of thesyringe mechanism 18. This increases the pressure on the saline in thesyringe barrel 24.

More particularly, the oscillating lever portion 64 includes a handle 66having a free first end 68 for engagement by the hand of an operator anda second end 69 pivotally secured to the fixed handheld lever portion62. The lever portion 64 is mechanically coupled to the toggle assembly22 for generating movement of the plunger 26 as the oscillating leverportion 64 is repeatedly compressed and released.

The toggle assembly 22 includes a first linkage member 74, a secondlinkage member 75, a third linkage member 76 and a fourth linkage member78. Each of the first linkage member 74, the second linkage member 75,the third linkage member 76 and the fourth linkage member 78 includes afirst end 74 a, 75 a, 76 a, 78 a and a second end 74 b, 75 b, 76 b, 78b. With this in mind, the first end 74 a of the first linkage member 74is fixedly secured to the second end 69 of the oscillating lever portion64 such that the second end 74 b of the first linkage member 74 movesabout an arc defined by the rotation of the oscillating lever portion 64at the pivot point 80. In accordance with a preferred embodiment theoscillating lever portion 64 and the first linkage member 74 are foundas a single piece, although it is appreciated they may be found asseparate pieces that are fixedly connected.

The second linkage member 75 is pivotally secured between the firstlinkage member 74 and the third and fourth linkage members 76, 78. Inparticular, the first end 75 a of the second linkage member 75 ispivotally connected to the second end 74 b of the first linkage member74. The second end 75 b of the second linkage member 75 is pivotallyconnected to both the second ends 76 b, 78 b of the third and fourthlinkage members 76, 78. The respective second ends 76 b, 78 b of thethird linkage member 76 and the fourth linkage member 78 are pivotallysecured to the second end 75 b of the second linkage member 75 such thatthe second, third and fourth linkage members 75, 76, 78 pivot about thesame axis. The first end 78 a of the fourth linkage member 78 ispivotally secured to the pump body 12 of the insufflation pump 10 whilethe first end 76 a of the third linkage member 76 is in communicationwith the plunger shaft 44 of the plunger 26 for driving the plungershaft 44 forward as the oscillating lever portion 64 is actuated inaccordance with the present invention.

In practice, the geometry of the oscillating lever portion 64 and thefirst linkage member 74 forces the second end 74 b of the first linkagemember 74 to follow a circular path at the end of first linkage member74 as the oscillating lever portion 64 moves through its pivoting motionrelative to the handheld lever portion 62. This movement causes forcedmovement of the second linkage member 75 that ultimately results inforced movement of the second ends 76 b, 78 b of the third and fourthlinkage members 76, 78. Because the first end 78 a of the fourth linkagemember 78 is pivotally mounted to the pump body 12 of the insufflationpump 10 (and is therefore unable to move along the length of the pumpbody 12), the first end 76 a of the third linkage member 76 is caused tomove a set distance (see FIGS. 3, 4 and 5). In accordance with apreferred embodiment, the set distance is approximately ½ inch. It isappreciated this distance may be adjusted by varying the lengths of thevarious linkage members.

The second end 48 of the plunger shaft 44 of the plunger 26 has achannel beam cavity 82 into which the first end 76 a of the thirdlinkage member 76 sits for actuation of the plunger shaft 44 along thelength of the pump body 12 (and particularly toward the second end ofthe syringe barrel 24). More particular, as the oscillating leverportion 64 is moved toward the fixed, handheld lever portion 62 (seeFIGS. 3-6), the first end 76 a of the third linkage member 76 is movedin a direction toward the distal, first end 30 of the syringe barrel 24.As a result of interaction between the first end 76 a of the thirdlinkage member 76 and the channel beam cavity 82 of the plunger shaft44, the movement of the first end 76 a of the third linkage member 76 istransferred to the plunger shaft 44 causing movement of the plunger 26toward the distal, first end 30 of the syringe barrel 24.

More particularly, the first end 76 a of the third linkage member 76 issecured to a carriage member 118 having a diametrically oriented guidepin 77 that is secured to the first end 76 a of the third linkage member76 and that passes through the plunger shaft 44. The carriage member 118engages the plunger shaft 44 via a locking pin 106 (discussed below)during forward motion (that is, toward the distal, first end 30 of thesyringe barrel 24) of the third linkage member 76 and the locking pin106 disengages from the plunger shaft 44 during rearward motion of thethird linkage member 76 and the carriage member 118. As such, when theoscillating lever portion 64 is compressed, the first linkage member 74,the second linkage member 75, the third linkage member 76 and the fourthlinkage member 78 move in a manner causing the first end 76 a of thethird linkage member 76 to move toward the distal, first end 30 of thesyringe barrel 24. During this distal motion, the carriage member 118 ismoved forward and, with the locking pin 106 of the carriage member 118engaging the plunger shaft 44, the plunger shaft 44 is forced in adirection toward the distal, first end 30 of the syringe barrel 24.

Once movement of the oscillating lever portion 64 is completed, that is,the compression cycle is completed, the oscillating lever portion 64 ofthe pistol grip 60 is released and the spring 70 bias in the oscillatinglever portion 64 causes the oscillating lever portion 64 to move to thereleased orientation. During this movement from the fully compressedorientation to the released orientation, the first linkage member 74,the second linkage member 75, the third linkage member 76 and the fourthlinkage member 78 move in a manner causing the first end 76 a of thethird linkage member 76 to move away from the distal, first end 30 ofthe syringe barrel 24. During this motion, the carriage member 118 movesrearwardly in the same direction as the first end 76 a of the thirdlinkage member 76 and the locking pin 106 of the carriage member 118disengages from the plunger shaft 44 in a manner allowing the carriagemember to move rearwardly without causing the plunger shaft 44 to moverearwardly. As is explained below in greater detail, the engagement anddisengagement of the locking pin with the plunger shaft is a result ofthe relative orientation of the ratchet teeth 86 and the shape of theend of the locking pin 106 which contact the ratchet teeth 86.

Movement of the carriage member 118 is controlled by the guide pin 77pivotally connected to the first end 76 a of the third linkage member76. In addition to providing for a pivotal connection between the firstend 76 a of the third linkage member 76 and the carriage member 118,ends 77 e of the guide pin 77 extend through slots 81 formed in thehousing of the pump body 12 to seat within opposite sides of thecarriage member 118 so as to link the carriage member 118 with the firstend 76 a of the third linkage member 76 to control the back and forthmovement thereof.

As briefly mentioned above, controlled movement of the plunger shaft 44in only one direction, that is, toward the distal end of the syringebarrel 24 is achieved by the provision of ratchet teeth 86 on the outersurface 88 of the plunger shaft 44. The ratchet teeth 86 are shaped anddimensioned for engagement with the locking pin of a toggle controlassembly 90 that selectively limits movement of the plunger shaft 44 byselectively engaging the ratchet teeth 86. As such, and with the lockingpin 106 of the toggle control assembly 90 engaging the ratchet teeth 86in a manner allowing for forward movement of the plunger shaft 44 withthe forward movement of the toggle control assembly 90, compression ofthe oscillating lever portion 64 causes forward movement of the firstend 76 a of the third linkage member 76 which (through the interactionof the toggle locking pin 106 of the carriage member 118 with theplunger shaft 44) moves the plunger shaft 44 forward toward the distal,first end 30 of the syringe barrel 24. Upon release of the oscillatinglever portion 64, it rotates away from the fixed, handheld lever portion62 causing the first end 76 a of the third linkage member 76 to moverearwardly. Because the toggle locking pin 106 of the carriage member118 at the first end 76 a of the third linkage member 76 and the ratchetteeth 86 are shaped to not engage when the locking pin 106 is moved in arearward direction relative to the plunger shaft 44, the carriage member118 (along with the locking pin 106 and the toggle control assembly 90)move rearwardly while the plunger shaft 44 remains stationary, and theoscillating lever portion 64 is ready for another cycle.

In accordance with a preferred embodiment, the portion of the plungershaft 44 diametrically and symmetrically below the ratchet teeth 86contains an axial slot through which the third and fourth linkagemembers 76, 78 enter and leave the plunger shaft 44. The entire plungershaft 44 is slip fit in the pump body 12 of the insufflation pump 10.This feature allows the plunger shaft 44 to be radially supported overits entire length. This feature reinforces the plunger shaft 44 so thatit does not deflect excessively in a direction perpendicular to thelongitudinal axis of the plunger shaft 44.

As briefly discussed above, a toggle control assembly 90 is provided. Inaddition, the insufflation pump 10 includes a piston control assembly92. The toggle control assembly 90 and piston control assembly 92 aredesigned so that the plunger shaft 44 may be driven down the entirelength of the syringe barrel 24 in one motion or in varying incrementsup to ½ inch for the present insufflation pump 10. Moving the plunger 26the entire length of the syringe barrel 24 permits the physician to fillthe syringe barrel 24 with saline by merely depressing the toggle andpiston control levers 94, 96 at the same time and pulling the plungershaft 44 to the left (as shown in FIGS. 1-6). Emptying of the syringemechanism 18 is achieved by pushing the end of the plunger shaft 44while the piston control lever 96 is depressed (as the toggle controllever 94 provides for movement of the plunger shaft 44 toward theproximal, second end 30 of the syringe barrel 24 as discussed above).These two procedures are very helpful in removing any trapped air in thesaline.

Both the toggle control assembly 90 and piston control assembly 92 relyupon spring biased lever mechanisms to selectively bring a locking pin106, 116 into contact with the ratchet teeth 86 of the plunger shaft 44.The toggle control assembly 90 is part of the carriage member 118 and,therefore, moves with the carriage member 118 as it is driven forwardand backward on the control of the toggle assembly 22. The togglecontrol assembly 90 includes a spring biased toggle lever arm 94pivotally mounted upon a pivot projection 100 secured to the carriagemember 118 that is wrapped about the barrel 24 for movement relativethereto. The toggle lever arm 94 includes a handle first end 102positioned on one side of the pivot projection 100 and an actuationsecond end 104 positioned on the opposite side of the pivot projection100. The toggle locking pin 106 extends downwardly from the second end104 such that it may be brought into and out of engagement with theratchet teeth 86 of the plunger shaft 44 to control the incrementalforward motion of the plunger 26. As discussed above, the ratchet teeth86 and the end of the toggle locking pin 106 are shaped such that theyengage when the locking pin 106 is moved in a forward direction towardthe first end 30 of the syringe barrel 24 so as to cause movement of theplunger shaft 44 in this direction. The ratchet teeth 86 and the end ofthe toggle locking pin 106 are further shaped to prevent engagement andallow relative movement between the toggle locking pin 106 and theplunger shaft 44 when the locking pin 106 is moved in a rearwarddirection away from the first end 30 of the syringe barrel 24 so as toallow movement of the carriage member while also allowing the plungershaft 44 to remain in its position.

The piston control assembly 92 includes a spring biased plunger leverarm 96 pivotally mounted upon a pivot projection 110 secured to the pumpbody 12. The plunger lever arm 96 includes a handle first end 112positioned on one side of the pivot projection 110 and an actuationsecond end 114 positioned on the opposite side of the pivot projection110. The plunger locking pin 116 extends downwardly from the second end114 such that it may be brought into and out of engagement with theratchet teeth 86 of the plunger shaft 44 to control the rearward motionof the plunger 26 when it is time to fill the syringe. The ratchet teeth86 and the end of the plunger locking pin 116 are shaped such that theyengage/disengage in opposite directions relative to the toggle lockingpin 106. In particular, the ratchet teeth 86 and the end of the plungerlocking pin 116 are shaped to engage when the plunger shaft 44 is movedin a rearward direction away from the distal, first end 30 of thesyringe barrel 24 so as to prevent undesired rearward motion. Becausethe piston control assembly 92 is fixedly secured to the pump body 12this prevents rearward movement of the plunger shaft 44 unless thepiston control assembly 92 is actuated to move the plunger locking pin116 away from the ratchet teeth 86 of the plunger shaft 44. The ratchetteeth 86 and the end of the plunger locking pin 116 are further shapedto prevent engagement and allow relative movement between the plungerlocking pin 116 and the plunger shaft 44 when the plunger shaft 44 ismoved in a forward direction toward the distal, first end 30 of thesyringe barrel 24 (for example, upon actuation of the toggle assembly22).

Access of the toggle locking pin 106 and the plunger locking pin 116 tothe ratchet teeth 86 of the plunger shaft 44 is facilitated by theprovision of a slot 115 in the housing through which the toggle lockingpin 106 and the plunger locking pin 116 pass. As discussed above, thetoggle control assembly 90 is mounted upon a cylindrical slide 118, inthe form of a circular ring portion, which is slip fit over the outerdiameter of the syringe barrel 24 for movement relative thereto.

In accordance with a preferred embodiment, the pistol grip 60 employedin accordance with the present configuration is used to increase thepressure on the saline maintained within the syringe mechanism 18.Repetitive squeezing and releasing of the pistol grip 60 drives theplunger 26 incrementally to the right down the entire length of thebarrel thereby increasing the pressure on the saline to a desired level.

If the saline pressure has to be raised or lowered for some reason, theposition of the pistol grip push button stop 122 should be adjusted. Thepush button stop 122 is utilized to adjust the positioning of thelinkage members. For example, if the hand force required to operate thepistol grip 60 is excessively high and difficult to use, the user maymove the push button stop 122 to another slot S-1 through S-7 on thehandheld lever portion 62 so as to lower the linkage angles. If the handforce is too low, the user may move the push button stop 12 to increasethe linkage angles.

More particularly, controlled application of the applied pressure levelis achieved by moving the push button stop 122 amongst slots S-1 throughS-7 found in the housing of the pump body 12 along the handheld leverportion 62 at the various pistol grip push button locations. The slotsS-1 through S-7 control the ability of the pistol grip 60 to movethrough an actuation cycle. More particularly, the push button stop 122is selectively inserted and removed from the slots S-1 through S-7 so asto adjust applied pressure levels. For example, if a medicalpractitioner is working at the level of slot 4 (S-4) and the medicalpractitioner wants to increase the pressure level to a higher value, themedical practitioner may simply actuate the pistol grip 60, pull thepush button stop 122 from slot 4 (S-4), increase the pressure on thepistol grip 60 and insert the push button stop 122 into slot 5 (S-5).

Where the user desires to decrease the applied pressure level, forexample, from the pressure level achieved at slot 4 (S-4) to thepressure level achieved at slot 3 (S-3), the medical practitioner willactivate the pistol grip 60 for the first half of its cycle and hold itthere. At this point, the medical practitioner will remove the pushbutton stop 122 from slot 4 (S-4) and move the push button stop 122 intoslot 3 (S-3). Thereafter, the medical practitioner will activate thepiston and toggle control assemblies 90, 92 to allow the plunger 26 tomove backward. Thereafter, the medical practitioner will gradually lowerthe hand load on the pistol grip 60 to allow the piston pressure loadingto be lowered.

It should be remembered that the toggle control assembly 90 and pistoncontrol assembly 92 hold the plunger 26 in place as discussed above. Assuch, one must continue to hold the pistol grip 60 at the pressure levelof slot 4 (S-4) for the first half of its cycle before operating thetoggle control assembly 90 and piston control assembly 92. Once togglecontrol assembly 90 and piston control assembly 92 are released, themedical practitioner may then gradually release the hand force on thepistol grip 60 to lower the pressure from the level at slot 4 (S-4) tothe level at slot 3 (S-3) in a gradual manner. The medical practitionermust be sure to maintain a suitably high hand load on the pistol grip 60to be sure the medical practitioner is operating the plunger 26, thetoggle control assembly 90 and the piston control assembly 92, becauseduring such motion the plunger 26 will be free to travel backwards asthe syringe loadings are up to 20 atmospheres under the toggle controlassembly 90 and piston control assembly 92. As such, the medicalpractitioner must hold the pistol grip 60 with a hand load as high asthat used to remove the push button stop 122 from slot 4 (S-4) becausethe backward motion of the plunger 26 will be driven by the pressure onthe plunger 26. Control of the pressure on the plunger 26 is achieved bygradually lowering the pressure on it using the hand operated pistolgrip 60.

In an effort to ensure operability of the present invention, amathematical analysis was conducted on a model of the insufflation pump10 as shown herein. The model simulated the use of the toggle controlassembly 90 and piston control assembly 92 using ten iterations of theangles involved. For example, the objective of the test was to inflatethe balloon to 20 atmospheres of pressure and transfer 20 ml of salineinto and out of the balloon. With this in mind, the respective controllevers of the toggle control assembly 90 and piston control assembly 92were held down so as to enable the plunger 26 to be fully displaced tothe right and left by pushing directly on the plunger shaft 44. To fillthe insufflation pump 10 with saline, for example, the medicalpractitioner holds down the respective levers of the toggle controlassembly 90 and piston control assembly 92 and draws saline into theinsufflation pump 10 by pulling the plunger shaft 44 to the left. Theend of the insufflation pump 10, of course, is submerged in a supply ofsaline. Any air bubbles in the insufflation pump 10 may be removed bydisplacing the piston forward and backward until all of the air bubblesare removed.

It should be noted, in an alternate embodiment, that the syringe end ofthe insufflation pump 10 may be made with an attachment member such that5 ml saline cartridges (for example) may be loaded into the insufflationpump 10 by merely depressing the actuator and drawing the plunger to itsmaximum retracted position. Depressing the actuator will then dischargethe fluid from the cartridge into attached tubing preferably securedthereto via a luer lock.

The present insufflation pump 10 may also be employed for easy andaccurate catheter flushing that, in many cases, can be easilyaccomplished by nurses, nurses' aides, and even the patient in manyinstances. The insufflation pump 10 is a small, sterile, prefilleddevice for single use that can be easily placed and deployed. Theinsufflation pump 10 is removed from the package and a small amount ofsaline is discharged using the actuator. After wiping with a sterilewipe, the insufflation pump 10 is connected to the catheter. A smallamount of fluid residing in the catheter is then withdrawn from thecatheter. Any air bubbles should be removed using current techniques. Onthe down stroke motion of the actuator, the sterile saline in theinsufflation pump 10 is forward flushed into the balloon portion of thecatheter. The device is then removed and discarded.

It is appreciated the insufflation pump 10 may be molded, for example,from General Electric HP or any other plastic suitable for medicaldevices. The enclosed drawings show an “O” ring seal on the piston. Thiswas selected for prototyping purposes and may be replaced byconventional syringe piston seals.

The insufflation pump 10 described herein can be used as a relativelylow pressure flushing device. With some modifications, such as theaddition of a pressure gauge and overall strengthening of the structure,the basic flusher concept may also be used to inflate balloons.

While the preferred embodiments have been shown and described, it willbe understood that there is no intent to limit the invention by suchdisclosure, but rather, is intended to cover all modifications andalternate constructions falling within the spirit and scope of theinvention.

The invention claimed is:
 1. An insufflation pump, comprising: a pumpbody having a first end and a second end; the pump body includes asyringe mechanism at the first end and an actuation mechanism at thesecond end, the syringe mechanism including a plunger, the syringemechanism includes a syringe barrel and the plunger is positioned withinthe syringe barrel for movement therein, the syringe barrel isintegrally formed with the pump body and includes a proximal, second endand a distal, first end, and the actuation mechanism includes a pistolgrip having a fixed, handheld lever portion and a spring loadedoscillating lever portion; wherein the plunger of the syringe mechanismand the actuation mechanism are linked by a toggle assembly coupledbetween the spring loaded oscillating lever portion and the plunger ofthe syringe assembly, the toggle assembly facilitating transfer of powerfrom the actuation mechanism to the syringe mechanism, the toggleassembly is composed of a plurality of linkage members driving theplunger forward as the spring loaded oscillating lever portion isactuated, the toggle assembly is secured to a carriage member having adiametrically oriented guide pin that is secured to the toggle assemblyand that passes through a plunger shaft of the plunger, such that thecarriage member engages the plunger shaft via a locking pin duringforward motion of the toggle assembly and the locking pin disengagesfrom the plunger shaft during rearward motion of the toggle assembly andthe carriage member.
 2. The insufflation pump according to claim 1,wherein the syringe barrel includes a pressure gauge in communicationwith an interior of the syringe barrel for measuring applied pressure.3. The insufflation pump according to claim 1, wherein the distal, firstend of the syringe barrel includes an outlet port through which fluid isdispensed or withdrawn as the plunger moves between the proximal, secondend of the syringe barrel and the distal, first end of the syringebarrel.
 4. The insufflation pump according to claim 3, wherein theoutlet port is shaped and dimensioned for selective attachment of acatheter thereto.
 5. The insufflation pump according to claim 1, whereinthe the plunger shaft includes a first end to which a seal member ismounted and a second end which is acted upon by the actuation mechanism.6. The insufflation pump according to claim 5, wherein the plunger shaftincludes ratchet teeth on an outer surface of the plunger shaft forcontrolling movement of the plunger shaft in only one direction.
 7. Theinsufflation pump according to claim 1, wherein the pump body includesan access opening shaped and dimensioned for the passage of the toggleassembly therethrough.
 8. The insufflation pump according to claim 1,wherein the toggle assembly includes a first linkage member, a secondlinkage member, a third linkage member and a fourth linkage member. 9.The insufflation pump according to claim 8, further including a pushbutton stop utilized to adjust positioning of the toggle assembly. 10.The insufflation pump according to claim 8, wherein a first end of thefirst linkage member is fixedly secured to a second end of theoscillating lever portion such that the second end of the first linkagemember moves about an arc defined by rotation of the spring loadedoscillating lever portion, a first end of the second linkage member ispivotally connected to a second end of the first linkage member, asecond end of the second linkage member is pivotally connected,respectively, to both a second end of the third linkage member and asecond end of the fourth linkage member and a first end of the fourthlinkage member is pivotally secured to the pump body while a first endof the third linkage member is in communication with the plunger fordriving the plunger forward as the oscillating lever portion isactuated.
 11. The insufflation pump according to claim 10, wherein thefirst end of the fourth linkage member is pivotally mounted to the pumpbody and unable to move along a length of the pump body, and the firstend of the third linkage member is caused to move a set distance. 12.The insufflation pump according to claim 10, wherein the second end ofthe plunger shaft has a channel beam cavity into which the first end ofthe third linkage member sits for actuation of the plunger shaft along alength of the pump body.
 13. The insufflation pump according to claim12, wherein the first end of the third linkage member is secured to thecarriage member and the diametrically oriented guide pin is secured tothe first end of the third linkage member and passes through the plungershaft, such that the carriage member engages the plunger shaft via thelocking pin during forward motion of the third linkage member and thelocking pin disengages from the plunger shaft during rearward motion ofthe third linkage member and the carriage member.
 14. The insufflationpump according to claim 1, further including a push button stop utilizedto adjust positioning of the toggle assembly.
 15. The insufflation pumpaccording to claim 1, further including a toggle control assembly and apiston control assembly.
 16. The insufflation pump according to claim 1,further including a toggle control assembly and a piston controlassembly.
 17. An insufflation pump, comprising: a pump body having afirst end and a second end; the pump body includes a syringe mechanismat the first end and an actuation mechanism at the second end, thesyringe mechanism including a plunger, the syringe mechanism includes asyringe barrel and the plunger is positioned within the syringe barrelfor movement therein, the syringe barrel is integrally formed with thepump body and includes a proximal, second end and a distal, first end,and the actuation mechanism includes a pistol grip having a fixed,handheld lever portion and a spring loaded oscillating lever portion;wherein the plunger of the syringe mechanism and the actuation mechanismare linked by a toggle assembly coupled between the spring loadedoscillating lever portion and the plunger of the syringe assembly, thetoggle assembly facilitating transfer of power from the actuationmechanism to the syringe mechanism, the toggle assembly is composed of afirst linkage member, a second linkage member, a third linkage memberand a fourth linkage member, wherein a first end of the first linkagemember is fixedly secured to a second end of the spring loadedoscillating lever portion such that the second end of the first linkagemember moves about an arc defined by rotation of the spring loadedoscillating lever portion, a first end of the second linkage member ispivotally connected to a second end of the first linkage member, asecond end of the second linkage member is pivotally connected,respectively, to both a second end of the third linkage member and asecond end of the fourth linkage member, and a first end of the fourthlinkage member is pivotally secured to the pump body while a first endof the third linkage member is in communication with the plunger fordriving the plunger forward as the spring loaded oscillating leverportion is actuated, wherein the toggle assembly is secured to acarriage member having a guide pin allowing for the carriage member toengage and disengage a plunger shaft in a manner causing movement of theplunger shaft.
 18. The insufflation pump according to claim 17, whereinthe first end of the third linkage member is secured to the guide pin ofthe carriage member and guide pin passes through the plunger shaft, suchthat the carriage member engages the plunger shaft via a locking pinduring forward motion of the third linkage member and the locking pindisengages from the plunger shaft during rearward motion of the thirdlinkage member and the carriage member.